COLchicine On-admission to Reduce Inflammation in Acute Coronary Syndrome (COLOR-ACS)

• Status: Not yet recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

Summary

Since colchicine is known to have anti-inflammatory effects and inflammation is an early component of acute coronary syndrome (ACS), this study aims to evaluate the acute effects of low-dose colchicine, in addition to atorvastatin, administered on-admission to statin-naive patients with non-ST elevation ACS scheduled for early invasive strategy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda USL Toscana Centro
• Treatments: Atorvastatin; Colchicine

Criteria

Inclusion Criteria:

• non-ST elevation acute coronary syndrome;

• ≥ 18 years;

• statin-naive.

Exclusion Criteria:

• prior statin therapy and/or colchicine treatment;

• known allergy or hypersensitivity to colchicine or statins;

• current treatment with potent inhibitors of CYP3A4 or P-glycoprotein (eg., Cyclosporin, antiretroviral drugs, antimycotics, erythromicin and clarythromycin);

• previous or scheduled administration of any immunosuppressive therapy;

• known active malignancy;

• severe kidney disease (creatinine > 3 mg/dl or dialysis)

• severe liver disease (ALT and/or AST, > double ref. normal values in case of (a) total bilirubin > double ref. normal values, or (b) alteration in coagulation (INR> 1,5);

• severe heart failure (NYHA class ≥ 3 or cardiogenic shock) at hospital presentation;

• severe acute or chronic gastro-intestinal disease (nausea, vomiting, diarrhea, malabsorption disease, malnutrition);

• pregnancy or lactation;

• current COVID-19 or other infectious disease;

• refusal of consent.